EDP514 / Enanta Pharma - LARVOL DELTA

PRECLINICAL PHARMACOKINETICS OF EDP-514, AN ORAL, ONCE-DAILY ANTIVIRAL TREATMENT FOR HEPATITIS B VIRUS (AASLD 2024) - "EDP-514 has a favorable PK profile and excellent target tissue penetration. The impressive combination of potent antiviral activity, high target tissue distribution, and clinical efficacy demonstrated from once-daily oral dosing, makes EDP-514 the ideal candidate for continued development in a combination regimen."

PK/PD data • Preclinical • Fibrosis • Gastrointestinal Cancer • Hepatitis B • Hepatocellular Cancer • Hepatology • Immunology • Infectious Disease • Inflammation • Oncology • Solid Tumor

Phase 1 Trial of the Safety, Pharmacokinetics, and Antiviral Activity of EDP-514 in Untreated Viremic Chronic Hepatitis B Patients. (PubMed, Clin Mol Hepatol) - "Nine patients reported treatment emergent adverse events (TEAEs) of mild or moderate severity with no discontinuations, serious AEs or deaths. In treatment-naïve viremic patients, oral EDP-514 was generally safe and well-tolerated, displayed PK profile supportive of once-daily dosing, and markedly reduced HBV DNA and HBV RNA."

Journal • P1 data • PK/PD data • Hepatitis B • Hepatology • Infectious Disease • Inflammation

EDP-514 in healthy subjects and nucleos(t)ide reverse transcriptase inhibitor-suppressed patients with chronic hepatitis B. (PubMed, Antivir Ther) - "EDP-514 was well tolerated, had a PK profile supporting once daily dosing, and reduced HBV RNA levels in NUC-suppressed CHB patients."

Journal • Hepatitis B • Hepatology • Infectious Disease • Inflammation

EDP-514, a potent pangenotypic class II hepatitis B virus core inhibitor, demonstrates significant HBV DNA and HBV RNA reductions in a phase 1b study in viremic, chronic hepatitis B patients (EASL-ILC 2022) - "EDP-514 was safe and well tolerated through 28 days of treatment in viremic CHB patients, with a linear PK profile supporting QD dosing and trough concentrations up to ∼24-fold above the paEC50. Profound antiviral activity was observed at Day 28 with mean HBV DNA reductions of up to 3.5 log, and mean HBV RNA reductions of up to 2.9 log with EDP-514 treatment. These results support further evaluation of EDP-514 in CHB patients."

Clinical • P1 data • Anemia • Gastrointestinal Disorder • Hematological Disorders • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Nephrology • Urology

EDP-514, a novel pangenotypic class II hepatitis B virus core inhibitor: final results of a 28-day phase 1b study in nuc-suppressed chronic hepatitis B patients (EASL-ILC 2022) - "EDP-514 was safe and well tolerated through 28 days of treatment in CHB nuc-suppressed patients, showed time-linear PK supportive of QD dosing with concentrations of up to ∼21-fold above the paEC50, and resulted in a higher log reduction in HBV RNA, up to a maximum of 2.8 log, was observed in HBeAg (+) patients receiving EDP-514."

Clinical • P1 data • Allergy • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Pain

A 2 PART STUDY EVALUATING EDP-721 IN HEALTHY SUBJECTS AND EDP-721 IN COMBINATION WITH EDP-514 IN PATIENTS WITH CHRONIC HEPATITIS B VIRUS INFECTION. (clinicaltrials.gov) - P1a/1b | N=26 | Terminated | Sponsor: Enanta Pharmaceuticals | N=106 ➔ 26 | Trial completion date: Aug 2023 ➔ Dec 2021 | Recruiting ➔ Terminated | Trial primary completion date: Aug 2023 ➔ Dec 2021; Due to adverse safety signals in Part 1 (HV)

Combination therapy • Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Study of EDP-514 in Healthy Subjects (Part 1) and Patients With Chronic Hepatitis B Virus Infection (Part 2) (clinicaltrials.gov) - P1a/1b; N=99; Completed; Sponsor: Enanta Pharmaceuticals; Recruiting ➔ Completed

Clinical • Trial completion • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Study of EDP-514 in Patients With Chronic Hepatitis B Virus Infection Who Are Not Currently on Treatment (clinicaltrials.gov) - P1b; N=25; Completed; Sponsor: Enanta Pharmaceuticals; Recruiting ➔ Completed

Clinical • Trial completion • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Enanta Pharmaceuticals Reports Financial Results for its Fiscal Fourth Quarter and Year Ended September 30, 2021 with Webcast and Conference Call Today at 4:30 p.m. ET (Businesswire) - P1, N=24; NCT04470388; Sponsor: Enanta Pharmaceuticals; "Reported Positive Clinical Data from Two Phase 1b Studies of EDP-514, a Hepatitis B Virus (HBV) Core Inhibitor, in Viremic and NUC-Suppressed Chronic HBV Patients...These data demonstrated that the 200 mg, 400 mg, and 800 mg doses were safe and well-tolerated through 28 days of treatment and displayed pharmacokinetics supportive of once-daily dosing. In viremic patients, treatment with EDP-514 resulted in mean HBV DNA reductions of 2.9, 3.3, and 3.5 logs at 28 days for the 200 mg, 400 mg, and 800 mg cohorts, respectively, compared to a 0.2 log reduction in the placebo group."

P1 data • PK/PD data • Hepatitis B • Infectious Disease

Enanta Pharmaceuticals Reports Positive Final Data from its Phase 1b Studies of EDP-514, a Novel Hepatitis B Virus Core Inhibitor (Businesswire) - P1, N=24; NCT04470388; Sponsor: Enanta Pharmaceuticals; "Enanta Pharmaceuticals, Inc...announced final Phase 1b data for EDP-514, a novel pangenotypic class II hepatitis B virus (HBV) core inhibitor, in conjunction with two posters presented at The Liver Meeting® 2021, hosted by the American Association for the Study of Liver Diseases (AASLD)...EDP-514 was generally safe and well-tolerated at 200 mg, 400 mg, and 800 mg doses for 28 days. EDP-514 was rapidly absorbed and its exposure increased with increasing multiple doses. EDP-514 exhibited pharmacokinetics suitable for once daily oral dosing, with Ctrough concentrations reaching up to ~20-fold above the protein-adjusted EC50. At Day 28, mean HBV RNA changes of -0.81, -1.12, 0.10, and -0.19 logs were observed in the 200 mg, 400 mg, 800 mg and placebo groups, respectively...Mean HBV RNA reductions were 2.9, 2.4, and 2.0 logs for the 200 mg, 400 mg, and 800 mg cohorts, respectively, compared to 0.02 log in placebo."

P1 data • Hepatitis B • Infectious Disease

[VIRTUAL] EDP-514, A POTENT PANGENOTYPIC CLASS II HEPATITIS B VIRUS CORE INHIBITOR, DEMONSTRATES SIGNIFICANT HBV DNA AND HBV RNA REDUCTIONS IN A PHASE 1b STUDY IN VIREMIC, CHRONIC HEPATITIS B INFECTED PATIENTS (AASLD 2021) - "EDP- 514 (200mg and 400mg) was safe and well tolerated through 28 days of treatment in viremic CHB patients, with a linear PK profile supporting QD dosing and trough concentrations up to ~20-fold above the paEC50. Significant antiviral activity was observed at Day 28 with mean HBV DNA reductions of 2.9 and 3.3 logs, and mean HBV RNA reductions of 2.9 and 2.4 logs, for 200mg and 400mg, respectively. These results support further evaluation of EDP-514 in CHB patients."

Clinical • P1 data • Anemia • Gastrointestinal Disorder • Hematological Disorders • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Nephrology • Urology

[VIRTUAL] EDP-514, A NOVEL PANGENOTYPIC CLASS II HEPATITIS B VIRUS CORE INHIBITOR: PRELIMINARY RESULTS OF A 28-DAY PHASE 1b STUDY IN NUC-SUPPRESSED CHB PATIENTS (AASLD 2021) - " Majorities of the sixteen subjects enrolled in the 200 and 400mg cohorts were male (69%), Asian (63%), HBeAg(-) (88%), and treated with tenofovir (88%), and the mean BMI in these cohorts was 27 kg/m2. EDP-514 (200mg, 400mg) was safe and well tolerated in CHB nuc-suppressed patients, showed time-linear PK supportive of QD dosing with concentrations of up to ~18-fold above the paEC50, and resulted in a mean 1 log drop in HBV RNA. A higher log reduction in HBV RNA, up to 2.8 logs, was observed in HBeAg(+) patients receiving EDP- 514 ."

Clinical • P1 data • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Pain

Enanta Pharmaceuticals Announces Data Presentations at AASLD’s The Liver Meeting 2021 (Businesswire) - "Enanta Pharmaceuticals, Inc...announced that the company will have two poster presentations showcasing clinical data for EDP-514, a novel pangenotypic class II hepatitis B virus (HBV) core inhibitor, at The Liver Meeting® 2021, hosted by the American Association for the Study of Liver Diseases (AASLD), being held November 12 – November 15, 2021. EDP-514 is being developed for use in combination treatments for patients with chronic HBV (CHB)."

P1 data • Hepatitis B • Infectious Disease

A 2 PART STUDY EVALUATING EDP-721 IN HEALTHY SUBJECTS AND EDP-721 IN COMBINATION WITH EDP-514 IN PATIENTS WITH CHRONIC HEPATITIS B VIRUS INFECTION. (clinicaltrials.gov) - P1a/1b; N=106; Recruiting; Sponsor: Enanta Pharmaceuticals; Not yet recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Drug-Drug Interaction Study Between EDP-514, Itraconazole, Carbamazepine, and Quinidine in Healthy Subjects (clinicaltrials.gov) - P1; N=72; Completed; Sponsor: Enanta Pharmaceuticals; Recruiting ➔ Completed

Trial completion • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A 2 PART STUDY EVALUATING EDP-721 IN HEALTHY SUBJECTS AND EDP-721 IN COMBINATION WITH EDP-514 IN PATIENTS WITH CHRONIC HEPATITIS B VIRUS INFECTION. (clinicaltrials.gov) - P1a/1b; N=106; Not yet recruiting; Sponsor: Enanta Pharmaceuticals

Clinical • Combination therapy • New P1 trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Enanta Pharmaceuticals Reports Positive Data from Phase 1b Study of EDP-514, a Hepatitis B Virus (HBV) Core Inhibitor, in Viremic Chronic HBV Patients (Businesswire) - P1, N=24; NCT04470388; Sponsor: Enanta Pharmaceuticals; "Enanta Pharmaceuticals, Inc...announced positive data from the first two dose cohorts of its Phase 1b study of EDP-514 in viremic chronic HBV patients who were not being treated with a nucleoside reverse transcriptase inhibitor (NUC). The data demonstrated that EDP-514, Enanta’s novel class II oral HBV core inhibitor, was safe and well-tolerated through 28 days of treatment, displayed pharmacokinetics (PK) supportive of once-daily dosing, and resulted in mean HBV DNA reductions of 2.9 and 3.3 logs at 28 days for the 200 mg and 400 mg cohorts, respectively."

P1 data • Hepatitis B • Infectious Disease

"$ENTA new corporate slide set—includes EDP-514 data reported today: https://t.co/4bKc2LzvKV" (@DewDiligence)

A Study of EDP-514 in Healthy Subjects (Part 1) and Patients With Chronic Hepatitis B Virus Infection (Part 2) (clinicaltrials.gov) - P1a/1b; N=98; Recruiting; Sponsor: Enanta Pharmaceuticals; Trial completion date: Dec 2020 ➔ Jul 2021; Trial primary completion date: Dec 2020 ➔ Jul 2021

Clinical • Trial completion date • Trial primary completion date • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Study of EDP-514 in Patients With Chronic Hepatitis B Virus Infection Who Are Not Currently on Treatment (clinicaltrials.gov) - P1b; N=24; Recruiting; Sponsor: Enanta Pharmaceuticals; Trial completion date: Apr 2021 ➔ Aug 2021; Trial primary completion date: Apr 2021 ➔ Aug 2021

Clinical • Trial completion date • Trial primary completion date • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Enanta Pharmaceuticals Reports Positive Data from Part 2 of its Phase 1b Study of EDP-514 in Chronic Hepatitis B Virus Patients on Treatment with a Nucleoside Reverse Transcriptase Inhibitor (Businesswire) - P1, N=98; NCT04008004; Sponsor: Enanta Pharmaceuticals; "Enanta Pharmaceuticals, Inc...announced positive data from the first two dose cohorts of Part 2 of its Phase 1b study of EDP-514 in chronic hepatitis B virus (HBV) patients already being treated with a nucleoside reverse transcriptase inhibitor (NUC). The data demonstrated that EDP-514, the Company’s novel class II oral HBV core inhibitor, was safe and well-tolerated, displayed pharmacokinetics (PK) supportive of once-daily dosing, and resulted in a mean reduction in HBV RNA of 1 log...as well as reporting data on our ongoing Phase 1b study in viremic patients later this quarter, which will provide key information about the impact of EDP-514 on HBV DNA levels."

P1 data • Hepatitis B • Infectious Disease

Drug-Drug Interaction Study Between EDP-514, Itraconazole, Carbamazepine, and Quinidine in Healthy Subjects (clinicaltrials.gov) - P1; N=72; Recruiting; Sponsor: Enanta Pharmaceuticals

Clinical • New P1 trial • Hepatitis B • Hepatology • Infectious Disease

[VIRTUAL] EDP-514, a novel pangenotypic class II hepatitis B virus core inhibitor: preliminary results of a phase 1 study in healthy adult subjects (EASL-ILC-I 2020) - "In the SAD phase, EDP-514/PBO was generally safe and well-tolerated, with favourable PK exposures supporting once daily dosing. Further data from MAD cohorts in HS will be presented."

Clinical • P1 data • Hepatitis B • Hepatology • Infectious Disease • Pain

Enanta Pharmaceuticals Reports Financial Results for its Fiscal Third Quarter Ended June 30, 2020 with Webcast and Conference Call Today at 4:30 p.m. ET (Businesswire) - "Pipeline Programs and Near-term Milestones: Hepatitis B (HBV): Core Inhibitor EDP-514: Initiated Phase 1b study in viremic HBV patients, with preliminary data expected in 1H 2021 Resumed Phase 1b study in NUC-suppressed HBV patients, with preliminary data expected in 2Q 2021."

P1 data • Trial status • Hepatitis B

A Study of EDP-514 in Patients With Chronic Hepatitis B Virus Infection Who Are Not Currently on Treatment (clinicaltrials.gov) - P1b; N=24; Recruiting; Sponsor: Enanta Pharmaceuticals

Clinical • New P1 trial • Hepatitis B • Infectious Disease